SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717AM2)(TERMINATED)

February 3, 2015 updated by: Merck Sharp & Dohme LLC

A Phase 2 Study of SCH 727965 in Subjects With Relapsed and Refractory Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia

Participants with acute myelogenous leukemia (AML) will be randomized to SCH 727965 or gemtuzumab ozogamicin. All participants with acute lymphoblastic leukemia (ALL) will receive SCH 727965. Part 1 of the study will determine the activity of SCH 727965 treatment in participants with AML and participants with ALL. Part 2 of the study will determine the activity of SCH 727965 treatment in participants with AML who experienced disease progression after standard treatment with gemtuzumab ozogamicin during Part 1.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • For participants with AML:

    • Age >=60 years, either sex, any race.
    • Diagnosis of CD33-positive AML by World Health Organization criteria.
    • Must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for transplant.
    • Acute promyelocytic leukemia who has relapsed following treatment with both all trans retinoic acid (tretinoin) and arsenic trioxide-based therapy is eligible.

  • For participants with ALL:

    • Age >=18 years, either sex, any race.
    • Diagnosis of ALL by World Health Organization criteria.
    • Must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for potentially curative therapy.
    • Eastern Cooperative Oncology group performance status of 0 or 1.
    • Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
    • Receiving treatment with hydroxyurea or leukapheresis to reduce elevated white blood cell count to <=30 x 10^9 is eligible, provided hydroxyurea and leukapheresis are discontinued at least 24 hours before initiation of study drug.

Exclusion Criteria:

  • Known central nervous system leukemia.
  • Previous hematopoietic stem cell transplantation.
  • Previous treatment with SCH 727965 or other cyclin-dependent kinase inhibitors.
  • For AML, previous treatment with gemtuzumab ozogamicin.
  • Known HIV infection.
  • Known active hepatitis B or C.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants with AML randomized to SCH 727965
Drug: SCH 727965
SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.
Active Comparator: Participants with AML randomized to gemtuzumab ozogamicin
Drug: Gemtuzumab ozogamicin
Gemtuzumab ozogamicin 9 mg/m2 IV on Day 1 and Day 15.
Other Names:
  • Mylotarg
Experimental: AML treated w/ SCH 727965 after prog. on gemtuzumab ozogamicin
Drug: SCH 727965
SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.
Experimental: Participants with ALL treated with SCH 727965
Drug: SCH 727965
SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate of initial treatment with SCH 727965 in subjects with AML or ALL.
Time Frame: Time to identified response or disease progression on SCH 727965 in Part 1 (approx. 5 months).
Time to identified response or disease progression on SCH 727965 in Part 1 (approx. 5 months).
Overall response rate in participants with AML treated with SCH 727965 after disease progression on comparator.
Time Frame: Time to identified response or disease progression on SCH 727965 in Part 2 (approx. 5 months).
Time to identified response or disease progression on SCH 727965 in Part 2 (approx. 5 months).

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to disease progression for initial treatment with SCH 727965 in subjects with AML or ALL.
Time Frame: Time to identified disease progression on SCH 727965 in Part 1 (approx. 5 months).
Time to identified disease progression on SCH 727965 in Part 1 (approx. 5 months).
Overall response rate and time to progression of treatment with gemtuzumab ozogamicin in subjects with AML.
Time Frame: Time to identified response or disease progression on gemtuzumab ozogamicin (approx. 5 months).
Time to identified response or disease progression on gemtuzumab ozogamicin (approx. 5 months).
Time to disease progression for treatment with gemtuzumab ozogamicin in participants with AML.
Time Frame: Time to identified disease progression on gemtuzumab ozogamicin (approx. 5 months).
Time to identified disease progression on gemtuzumab ozogamicin (approx. 5 months).
Time to disease progression in participants with AML treated with SCH 727965 after disease progression on gemtuzumab ozogamicin
Time Frame: Time to identified disease progression on SCH 727965 in Part 2 (approx. 5 months).
Time to identified disease progression on SCH 727965 in Part 2 (approx. 5 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

November 25, 2008

First Submitted That Met QC Criteria

November 25, 2008

First Posted (Estimate)

November 26, 2008

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 3, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04717

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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